Associate Director, CMC Project Management

Job Description

This individual will also oversee project management including timelines, budgets, invoices, reports and documentation, and may assist with regulatory filings.

This position reports to the Chief Technical Officer and is responsible for the following:

• Create and execute against integrated cross-functional project plans, leading the integrated CMC strategy.
• Translate program strategy into cohesive development, manufacturing, and supply plans with clear milestones and deliverables.
• Drive cross-functional alignment in close partnership with Clinical Development, Regulatory Affairs, Quality, Supply Chain, Commercial, and Finance teams.
• Guide and lead project performance, risk and financial management, and issues resolution for functional groups.
• Provide direction on requirements to meet internal and external stakeholders’ expectations.
• Ensure CMC activities are executed in lockstep with clinical timelines, regulatory milestones, and commercial launch plans.
• Serve as the CMC representative on program governance teams, influencing key decisions and trade-offs across functions.

Budget Planning & Financial Stewardship

Develop and manage comprehensive CMC budgets, including development, manufacturing, and supply chain costs.

• Drive financial planning, forecasting, and scenario modeling to support program and portfolio decisions.
• Identify and implement cost optimization strategies without compromising quality, timelines, or regulatory compliance.
• Partner with Finance to ensure transparency, accountability, and disciplined capital allocation.
• Evaluate investment trade-offs and provide data-driven recommendations to senior leadership.
• Define 3y spending plans and hold quarterly financial updates.

Strategic CMO/CDMO Oversight & External Partnerships

Working with functional leads (Drug Substance, Drug Product, and Analytical Department Heads), execute a robust external manufacturing strategy, including selection, onboarding, and management of CMOs/CDMOs.

• Establish CDMO governance systems in conjunction with QA leadership such as performance metrics, and KPIs.
• Ensure accountability for delivery, quality, cost, and timelines.
• Proactively identify and mitigate risks across the external network, including capacity, quality, and supply continuity risks.
• Drive strong, collaborative partnerships while maintaining rigorous oversight and escalation processes when needed.

Program Leadership & Governance

Operate as a GM for the program for CMC, accountable for delivery against timeline, cost, and quality objectives.

• Provide clear, concise communication and executive-level updates on risks, progress, and mitigation strategies.
• Build alignment across stakeholders and drive decisive, forward-looking decision-making.